Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 008983
Company: ROCHE
Company: ROCHE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ARFONAD | TRIMETHAPHAN CAMSYLATE | 50MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/26/1954 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/21/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/26/1978 | SUPPL-10 | Labeling |
Label is not available on this site. |
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05/06/1976 | SUPPL-9 | Labeling |
Label is not available on this site. |